1. “It is the responsibility of those of us involved in today’s biomedical research enterprise to translate the remarkable scientific innovations we are witnessing into health gains for the nation” NIH Roadmap Initiative From Bench to Bedside Elias Zerhouni, MD Director, NIH NEJM 2005

2. NIH roadmap initiatives New pathways to discovery (bench science) New pathways to discovery (bench science) New approaches to unravel the complexities of biologic systems (proteomics, metabolomics, new tools/probes) New approaches to unravel the complexities of biologic systems (proteomics, metabolomics, new tools/probes) Research teams of the future (bedside science) Research teams of the future (bedside science) Promotion of interdisciplinary research and training Promotion of interdisciplinary research and training Removing barriers to interdisciplinary research Removing barriers to interdisciplinary research Promoting public-private sector liaisons Promoting public-private sector liaisons Re-engineering the clinical research enterprise Re-engineering the clinical research enterprise Creation of research networks Creation of research networks Clinical research workforce training Clinical research workforce training Translational research; “bench to bedside” teams Translational research; “bench to bedside” teams

3. Key Functions of the CTSA CTSA serve to concentrate basic, translational and clinical investigators, community clinicians, clinical practices, networks, professional societies and industry CTSA serve to concentrate basic, translational and clinical investigators, community clinicians, clinical practices, networks, professional societies and industry Establish innovative clinical/translational research Establish innovative clinical/translational research Bridging of clinical and basic scientists Bridging of clinical and basic scientists Expansion of biomedical informatics Expansion of biomedical informatics Biostatistics, research ethics programs Biostatistics, research ethics programs Community engagement Community engagement Education and training (MS or PhD) Education and training (MS or PhD) Establish communications with other centers and industry Establish communications with other centers and industry

4. Impact of CTSA’s Funding for GCRC’s will be phased out over next 3-5 years. Funding for GCRC’s will be phased out over next 3-5 years. Functions of GCRC will be included in CTSA Functions of GCRC will be included in CTSA Lack of Institutional Commitment will impact applicant institutions Lack of Institutional Commitment will impact applicant institutions No ‘home’; no award No ‘home’; no award Will require interdisciplinary interaction Will require interdisciplinary interaction Academic and clinical silos will need to integrate Academic and clinical silos will need to integrate Will require closer collaboration between basic, translational, and clinical scientists Will require closer collaboration between basic, translational, and clinical scientists Lack of an Institutional CTSA will impact future applications to NIH Lack of an Institutional CTSA will impact future applications to NIH

5. Following the Roadmap Step 1: Step 1: Institutional Clinical and Translational Science Award (CTSA; RFA; U54 mechanism) Institutional Clinical and Translational Science Award (CTSA; RFA; U54 mechanism) Direct application for full award Direct application for full award Planning application Planning application Due March 27, 2006 (and yearly thereafter) Due March 27, 2006 (and yearly thereafter) Full awards Full awards $30 million available for FY 2006 $30 million available for FY 2006 Up to $6 million in total costs for 5 years Up to $6 million in total costs for 5 years 4-7 awards for FY 2006 for full award 4-7 awards for FY 2006 for full award Planning awards Planning awards $11.5 million available for FY 2006 $11.5 million available for FY 2006 50 awards for FY 2006 50 awards for FY 2006